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510(k) Data Aggregation

    K Number
    K222635
    Device Name
    Premier Resolution System
    Manufacturer
    Trinity Biotech (Primus Corporation, dba Trinity Biotech)
    Date Cleared
    2023-08-04

    (338 days)

    Product Code
    GKA
    Regulation Number
    864.7415
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trinity Biotech (Primus Corporation, dba Trinity Biotech)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant. The Premier Resolution System is intended for Professional Laboratory Use only. The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech. The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.
    Device Description
    The Premier Resolution System consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC).
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